82 Clinical Trials for Various Conditions
The purpose of the study is to test whether body-worn wireless motion sensors can measure dyskinesias (involuntary movements caused by medications) in individuals with Parkinson disease (PD) independent of voluntary activity being performed and other PD motor symptoms (e.g. tremor).
The Researchers are trying to learn more about how individuals break down and process medications based on their genes. The Researchers want to find out whether subjects will have fewer side effects if they take different medications based on their pharmacogenomics profile.
This randomized controlled pragmatic pilot study examines the feasibility and acceptability of a population health-based deprescribing intervention that leverages a polypharmacy risk prediction model. It includes four arms (2 intervention and 2 control arms) and uses a parallel arm study design.
This study aims to compare two FDA approved medications (aripiprazole and risperidone) for the treatment of behavioral dysregulation in children with autism spectrum disorders. This trial, done in the context of routine clinical care, will seek to evaluate whether aripiprazole or risperidone is associated with more weight gain in children.
The purpose of this study is to compare postoperative pain control after minimally invasive coronary artery bypass grafting for patients who receive an intercostal block (an anesthetic medicine injected in an area under the ribs) in the operating room and IV acetaminophen (Tylenol) to those who receive an intercostal block and On-Q pain pump catheter (a balloon pump attached to 2 small tubes near your procedure site that automatically delivers pain medicine).
The purpose of this study is to evaluate the hemodynamics and adverse event profile in comparison between two treatment arms, one using an admixture of propofol and etomidate at a ratio by volume of 25%/75% (P2E7), and one using an admixture of propofol and etomidate at a ratio by volume of 75%/25% (P7E2), for anesthesia during endoscopic procedures at the Clements University Hospital (CUH) endoscopy lab (Endo).
Use of polypharmacy has significantly increased over the past two decades, which has unproven clinical benefit and is associate with an increased the risk of adverse side effects. Pharmacogenetic assays, such as the Genecept® Assay, have the purported benefit of being able to predict response(s) to specific medication based on genetic markers. Thus, this study is a 12-week open-label, naturalistic study of the provision of pharmacogenetic testing and a computerized decision tool for providers to determine the potential efficacy of the assay to reduce polypharmacy and improve patient outcomes.
The investigators are developing a questionnaire that can quickly measure the impact that epilepsy has on a person's life. This questionnaire will be useful in following whether the impact of epilepsy increases, decreases or stays the same over time. The results also may point out areas that would benefit from discussion or attention in visits with your doctor.
The primary goal of this study is to investigate the efficacy of deutetrabenazine treatment of TD in this previously untreated patient population. Compare movement disorder deutetrabenazine treatment response in persons with IDD to response seen in patients without IDD treated with deutetrabenazine in other treatment settings (per literature review). Compare global deutetrabenazine treatment response with validated instruments. In addition, we plan to: * Assess the safety of deutetrabenazine in the treatment of TD in persons with IDD. * Assess change in Activities of Daily Living (ADLs) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated ADL instrument. * Assess change in Quality of Life (QOL) in persons with IDD and TD treated with deutetrabenazine, utilizing a validated QOL instrument. * Assess caregiver burden with a validated caregiver burden instrument. In this study, 25 participants with IDD and TD will undergo Deutetrabenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to deutetrabenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication. This will be an open-label, Phase 4 study.
The goal of this open-label clinical trial is to test the safety and efficacy of valbenazine treatment in patients with Intellectual/Developmental Disability (IDD) who have a diagnosis of Tardive dyskinesia (TD). The main questions this study aims to answer are: * Does valbenazine treatment of TD in the previously untreated patient population of adults with IDD produce comparable amelioration of signs of movement disorder as what has historically been reported in adults without IDD? * Is valbenazine treatment of TD in persons with IDD as safe as what has historically been reported in adults without IDD? * Does valbenazine treatment improve Quality of Life (QOL) in persons with IDD and TD treated with valbenazine? * Does valbenazine treatment produce positive change in Activities of Daily Living (ADLs) in persons with IDD and TD? * Does valbenazine treatment of TD in persons with IDD reduce caregiver burden? In this study, 25 participants with IDD and TD will undergo valbenazine treatment for 24 weeks. The participants will be seen for a total of 5 visits: at baseline, and at follow up visits at 3 weeks, 6 weeks, 12 weeks, and 24 weeks. This study does not include a comparison group. Therefore, researchers will compare the response of the study participants to valbenazine treatment with those from a previous reported work that resulted in the FDA approval of this medication.
Patient transfer between sites of care is regular practice during an episode of care in our current health care system. Yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. A common iatrogenic harm precipitated at the time of transfer is harm from drug prescribing, or adverse drug events (ADEs). In this study we will evaluate a medication reconciliation tool developed to help providers make effective prescribing decisions at the time of transfer between VA sites of care (Improved Prescribing after Transfer (IPT)). We will evaluate the quantitative effectiveness of the tool in reducing transition drug risk and ADEs. We additionally will conduct focus group discussions and cognitive task analysis among end-users to better understand how providers make drug-prescribing decisions at the time of transfer and to assess factors influencing effective use of the tool.
The purpose of this study is to determine the relationship between dexamethosone (steroid) and children's sleep and fatigue.
The purpose of this study is to provide the first empirical examination of the effects of Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and physiological measures of sexual function in women who are experiencing sexual disorders secondary to antidepressants.
The purpose of this study is to see if the participant's genetic profile and clinical factors (age, drug dose, etc.) affect drug outcomes (i.e. serious bleeding) that the participant may have experienced since taking the drug (direct oral anticoagulant) for preventing blood clots from forming in the blood vessels.
This retrospective study's objective is to evaluate if Cipherome's algorithm could have predicted the serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).
Medication discrepancies, defined as unintentional differences found between patients' medical records and patients' reports of the medication they are taking, occur frequently after hospital discharge, predisposing to adverse drug events (ADEs), emergency department visits and readmissions. Resolving medication discrepancies - medication reconciliation - is mandated at every care transition, but little is known about intervention strategies to improve medication reconciliation in the post-discharge period, when patients may lack prompt access to primary care and are at high risk for ADEs. To address this gap, the investigators developed and pilot tested the Secure Messaging for Medication Reconciliation Tool (SMMRT), with a pharmacist communicating with Veterans to review medications and reconcile discrepancies after hospital discharge via Secure Messaging (SM), within My HealtheVet (MHV), VA's patient portal. The objectives of The SMMRT Trial are therefore To optimize the end-users' experience with SMMRT through usability testing and refinement of the tool; To conduct a randomized controlled trial (RCT) of usual care vs. usual care plus MHV Training vs. usual care plus MHV Training plus SMMRT to reduce hospital utilization; To evaluate how Veterans and staff perceived the impact of SMMRT on routine clinical practices and, specifically, on Veterans' interactions with their primary care providers.
Inappropriate prescribing is the fundamental upstream driver of the opioid epidemic. Objective measures to determine the appropriateness of an opioid intervention, provide monitoring of the therapy for adequacy of dose and detection of tolerance or hyperalgesia would eliminate the subjective nature of opioid mediated pain management and obviate iatrogenic facilitation of opioid abuse. The present study is designed to objectively determine whether our device can pain type and determine analgesic efficacy thereby optimizing treatment selection and opioid management.
This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.
This is an observational study for patients with breast cancer that will be treated with doxorubicin (Adriamycin) and/or trastuzumab (Herceptin). The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 15 years.
The purpose of this investigation is to assess the effectiveness of a multi-disciplinary Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older admitted to Oregon Health \& Science University's hospital medicine service. The ACE program will aim to improve the quality of care of older patients in the investigators hospital by implementing focused interventions and recommendations specific to geriatric needs and syndromes, including: reduced fall rate, decreased incidence and duration of delirium, early recognition and treatment of impaired mobility and function, careful minimization of medication use, prevention of unnecessary catheter and restraint use, decreased hospital readmission rates, improved transitional care following hospital discharge, and high levels of patient and referring physician satisfaction. Additionally, the ACE program aims to improve resident and student competence in treating geriatric syndromes, and to improve staff and learner satisfaction with caring for older adults. ACE programs have been well studied at other institutions, so the investigators will be implementing a program that is already standard of care, and studying the elements that are unique to OHSU. This will be a quality improvement project. Study participants will be a convenience sample of OHSU faculty, staff, residents and students who are employed by or on rotation with General Medicine Team 1 of the Medicine Teaching Service. Faculty, staff, and learners (ACE team members) will receive the ACE training. Study personnel will conduct prospective and retrospective chart review of patients admitted to the ACE service to determine outcomes as noted above.
Current management of hypertension in PD motor fluctuators is flawed. The current practice often is to treat transient hypertensive spikes reported by patients or measured in clinics with anti-hypertensive medications. This may contribute to morbidity by worsening orthostatic hypotension and increasing fall risk. There is a scarcity of literature on this subject and there is no documentation of severe hypertension with rises in systolic blood pressure exceeding 50% of baseline occurring during motor "OFF". There are two studies that have demonstrated that blood pressure fluctuation can occur in motor fluctuators during the "OFF" state1,2. The study by Baratti et al measured blood pressure in 13 Parkinson's disease patients, 7 with motor fluctuations and 6 without fluctuations. In the fluctuators, the mean systolic/diastolic blood pressures were significantly higher than the non-fluctuators during the "OFF" state but not the "ON" state.
The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer. Participants will be randomized to either an intervention or control group. Outcomes such as symptom severity, quality of life, and resource use will be examined.
During the study, members of different online and offline communities will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference. Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.
There has been a dramatic paradigm shift over the last 25 years within cancer care due to the onset of many new targeted therapies and a transition from inpatient to outpatient care. Hand in hand with this shift has been the increased development and use of oral anti-cancer drugs, including cytotoxic chemotherapies that patients self-administer at home versus administration of an intravenous product at an infusion center. One of the main drivers for the growth and popularity of oral chemotherapy has been patient preference. However, an incorrect assumption exists among patients that oral therapy is associated with minimal side effects. According to the 2008 NCCN Task Force Report on Oral Chemotherapy, "some patients may incorrectly assume that oral chemotherapy is not "real" chemotherapy and is more akin to taking a vitamin or antibiotic. Furthermore, patients must understand that oral equivalents of cytotoxic therapies, such as capecitabine, have side effects that are similar to their parenteral counterparts in this case, fluorouracil. The need to monitor for side effects and titrate dosages increases the complexity of oral chemotherapy regimens". Self-administration of these complex oral therapies causes patients to become more autonomous in their care, without medical supervision of doses between office visits. Due to the lack of oversight, there is a concern of compromised efficacy if patients take less than the prescribed doses, or increased, sometimes life-threatening, toxicity, often between office visits, if more than the prescribed dose is taken. Both daily dose and schedule can be complicated for patients to comprehend and follow. Capecitabine is a particularly complex oral chemotherapy, with 2 pill dose sizes, dosing by Body Surface Area (BSA), twice a day dosing, and days of on therapy and days off of therapy. For this reason, capecitabine has been chosen as the backbone for regimens that will be studied. As noted in section 5.3 capecitabine might be combined with other oral chemotherapies, Parenteral chemotherapy or radiation therapy. The investigators believe there is an opportunity in this space to improve oral chemotherapy adherence by walking patients through how and when to take their oral therapies remotely, as well as to better manage toxicity by gathering more information from the patient during their treatment.
The study test whether the NSAID allosteric site of human sulfotransferase 1A1 (SULT1A1) is operative in humans. The study will test the effects of mefenamic acid (MEF) on the sulfonation of acetaminophen (APAP, a SULT1A1 specific substrate) and dehydroepiandrosterone (DHEA, a SULT2A1 substrate). If the allosteric site is active in vivo, MEF is predicted to result in a decrease in sulfonation of APAP (MEF inhibits SULT with high affinity (Ki = 23 nM), and to have no effect on sulfonation of the DHEA (MEF has little or no effect on SULT2A1 activity).
The goal of this clinical trial is to assess the safety, tolerability and pharmacokinetics of ATL-001 (ciclopirox olamine) in healthy volunteers
Primary objectives: 1. To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers 2. To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.
The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Health-related quality of life will be assessed pre-vaccination (Day 1) and on Days 3 and 9 post-vaccination.
To evaluate the safety and efficacy of 0.5% GL101 topical gel administered twice daily for 28 days in ameliorating adverse ocular side effects in patients under ongoing treatment with glaucoma medications.